- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551428
The Effect of Sleep Quality on Mental and Physical Health
The Sleep Stress Connection: Investigating How Sleep Quality Affects Mental and Physical Health
This study aimed to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.
A mixed methods approach will be used including:
a pre-test questionnaire and physiological measurements that depend on scales for measuring to assess sleep patterns: DASS21, fatigue assessment scale, Epworth sleeping scale, and SF-12 health survey scoring.
All of that will highlight the importance of addressing sleep quality as a crucial factor in promoting overall well-being.
Study Overview
Status
Conditions
Detailed Description
This study aims to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.
A mixed methods approach will be used including: a pre-test questionnaire and physiological measurements that depend on scales for measuring to assess sleep patterns: DASS21, fatigue assessment scale, Epworth sleeping scale, and SF-12 health survey scoring.
All of that will highlight the importance of addressing sleep quality as a key factor in promoting overall well-being.
In conclusion, understanding the intricate relationship between sleep quality, stress, and mental and physical health is vital for promoting holistic well-being, developing effective interventions, and improving health outcomes at individual, community, and societal levels. By recognizing the significance of this research, we can work towards creating a healthier and more resilient population.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Noran Abdallah Essa, Bachelor student
- Phone Number: +201069700624
- Email: noraneisa36@gmail.com
Study Contact Backup
- Name: Reda Fathi Elbosaty, Bachelor student
- Phone Number: +201555401579
- Email: reda_1661a@pt.kfs.edu.eg
Study Locations
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-
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Kafr Ash Shaykh, Egypt, 33516
- Kafrelsheikh University
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Contact:
- Abdelrazek Youssef Desouky, PhD, prof
- Phone Number: 002- 047-3109590
- Email: president@kfs.edu.eg
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Contact:
- Ismail Ismail ElSayed, PhD, prof
- Phone Number: +201017524003
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-university students between the ages of 18 and 35.
Exclusion Criteria:
- People with diseases and conditions can significantly affect sleep quality, cause fatigue, and impact mental and physical health along with relevant medications that might exacerbate these issues:
Diseases and conditions:
- Restless Legs Syndrome (RLS)
- Bipolar Disorder
- Fibromyalgia:
- Parkinson's Disease
- Multiple Sclerosis (MS)
- Thyroid Disorders
Medication:
- Sleep aids
- antidepressants
- diuretics
- antihistamines
- hormonal medications
- blood pressure medications
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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university students between age of 15 and 35
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stress
Time Frame: Week
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Measurement tool: THE DASS-21 scale Unit of measurement:The DASS-21 (Depression, Anxiety, and Stress Scale - 21 items) measures psychological distress across three domains: depression, anxiety, and stress. Each of the three scales consists of 7 items, and respondents rate their experience over the past week on a 4-point Likert scale The scores for each domain are summed to provide a total score, which can then be categorized into different severity levels (normal, mild, moderate, severe, and extremely severe) based on specific cutoff points. Each of the three domains is measured separately, and the resulting scores are typically reported as a total score for each domain. |
Week
|
|
Sleep quality
Time Frame: Week
|
Measurement tool:epwoth sleepiness sclae (ESS). Unit of measurement: The **Epworth Sleepiness Scale (ESS)** is used to assess daytime sleepiness. It consists of 8 scenarios, and respondents rate their likelihood of dozing off in each situation on a scale from 0 to 3: The total score is obtained by summing the scores for all 8 items, resulting in a score that can range from **0 to 24**. Higher scores indicate greater levels of daytime sleepiness. The following cutoff values are often used to interpret the results: These scores help in identifying individuals who may require further evaluation for sleep disorders. |
Week
|
|
Mental and physical health
Time Frame: 4 weeks
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Measurement tool:SF-12 health survey scoring. Unit of measurement: The SF-12 health survey scoring uses a unitless scale to measure health-related quality of life. The scores range from 0 to 100, with higher scores indicating better health status. The survey assesses physical and mental health across various dimensions but does not assign specific units of measurement like inches or pounds; instead, it provides a standardized score reflecting overall health. |
4 weeks
|
|
Fatigue
Time Frame: Week
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Measurement tool: fatigue assessment scale. Unit of measurement: Based on subjective rating"numerical scale" |
Week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Ali Torad, PhD, lecturer, Faculty of physical therapy Kafrelsheikh university
- Study Director: Tamer Mohamed El-Saeed, PhD, associate professor, Cairo University
- Principal Investigator: Reda Fathi Elbosaty, Bachelor student, Faculty of Physical Therapy, Kafrelsheikh University
- Principal Investigator: Noran Abdallah Essa, Bachelor student, Faculty of Physical Therapy, Kafrelsheikh University
Publications and helpful links
General Publications
- Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.
- Sovold LE, Naslund JA, Kousoulis AA, Saxena S, Qoronfleh MW, Grobler C, Munter L. Prioritizing the Mental Health and Well-Being of Healthcare Workers: An Urgent Global Public Health Priority. Front Public Health. 2021 May 7;9:679397. doi: 10.3389/fpubh.2021.679397. eCollection 2021.
- Scott AJ, Webb TL, Martyn-St James M, Rowse G, Weich S. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Dec;60:101556. doi: 10.1016/j.smrv.2021.101556. Epub 2021 Sep 23.
- Uccella S, Cordani R, Salfi F, Gorgoni M, Scarpelli S, Gemignani A, Geoffroy PA, De Gennaro L, Palagini L, Ferrara M, Nobili L. Sleep Deprivation and Insomnia in Adolescence: Implications for Mental Health. Brain Sci. 2023 Mar 28;13(4):569. doi: 10.3390/brainsci13040569.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KFSIRB200-267
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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